Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091001
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NISOLDIPINE NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
NISOLDIPINE NISOLDIPINE 17MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
NISOLDIPINE NISOLDIPINE 25.5MG TABLET, EXTENDED RELEASE;ORAL Prescription None No No
NISOLDIPINE NISOLDIPINE 34MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/26/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091001s000ltr.pdf

NISOLDIPINE

TABLET, EXTENDED RELEASE;ORAL; 8.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NISOLDIPINE NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091001 MYLAN
SULAR NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020356 COVIS PHARMA BV

TABLET, EXTENDED RELEASE;ORAL; 17MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NISOLDIPINE NISOLDIPINE 17MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091001 MYLAN
SULAR NISOLDIPINE 17MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020356 COVIS PHARMA BV

TABLET, EXTENDED RELEASE;ORAL; 34MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NISOLDIPINE NISOLDIPINE 34MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091001 MYLAN
SULAR NISOLDIPINE 34MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020356 COVIS PHARMA BV

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